MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT

Catalog Number	4A5108
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the issues include touch less intermittent catheter tips bent like umbrella handles or excessive gel inside the catheter tube, preventing urine flow.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.No actions can be taken at this time since a root cause was not identified.Visual evaluation of the returned one-photo sample noted several opened (without original packaging), touch less intermittent catheter tips bent.Visual inspection of the one-photo sample noted that the introduce tips of the touch less intermittent catheters were bent.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: instructions for use: preparing for catheterization: 1.Open kit and remove contents.2.The gloves are not necessary to maintain aseptic conditions during the procedure.The gloves are for the operator's protection.Male/female catheterization: 1.Remove cap from insertion tip while squeezing tabs.Save cap for closing the bag.2.Slide the catheter halfway into the insertion tip.3.Male - prepare the male urethral meatus and the surrounding area with povidone-iodine swabs provided.Female - prepare the female urethral meatus by holding the outer labia apart and prep the urethral meatus and surrounding area with povidone iodine swabs provided.4.Male - holding the penis, advance the insertion tip into the urethra no further than the flange base.Female - spread the inner labia, advance the insertion tip into the urethra no further than the flange base.Release the inner labia.5.Place your nondominant hand on the finger control guide to stabilize catheter in urethra.With your dominant hand, grasp catheter through bag approximately 1" below the finger control guide and push catheter into urethra.The catheter should be introduced by short, repetitive pushing motions.Repeat motions until catheter reaches bladder and urine starts to flow.6.Allow urine to flow freely, making certain the catheter guide is elevated at least 4" above lower portion of the bag.Allow flow until bladder is empty or until bag is filled.Precaution: it is recommended that the collection bag be held.The catheter could possibly separate from the collection bag when urine increases weight of the bag.7.Withdraw the catheter from the urethra.Remove the remaining portion of the catheter from the collection bag by pulling it through the insertion tip.Note: the catheter is designed to pass through the insertion tip.8.The filled collection bag may be closed by replacing the cap over the insertion tip.Make sure the cap snaps on securely.Specimen collection: to collect a specimen, obtain a sample cup/tube and alcohol wipe.Remove guide tip by pulling tab(s) upward from bag.Wipe port with alcohol.Pour specimen through port at top of bag into cup/tube.Draining bag: remove insertion tip by pulling tab(s) upward from bag.Drain urine through port at top of bag.Correction: a, d, h udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the issues include touch less intermittent catheter tips bent like umbrella handles or excessive gel inside the catheter tube, preventing urine flow.Per additional information received on 28oct2024, the customer had encountered 36 defective catheters.The issues include catheter tips bent like umbrella handles or excessive gel inside the catheter tube, preventing urine flow.Per additional information received on 29oct2024, the 36 defective items, they sent in the previous email were collected from july to the present, with many defects coming from lot number ngjr2350, which has an expiration date of 28feb2026.Additionally, the boxes were not damaged.The total number of defective items collected so far was 36.Per additional information received on 09nov2024, the customer received the 36 items well.The lot number is ngju0708, which was different from the previous one.The hope there were no defective products this time.Also, would like to try other products besides bard.Per follow up via phone on 17dec2024, the issue with the item, the issues include catheter tips bent like umbrella handles or excessive gel inside the catheter tube, preventing urine flow.Per follow up via phone on 18dec2024, the representative unsure if they still would have the defective product since it was requested to only hold it for 2-3 weeks (until november 22).Per follow up via phone on 23dec2024, there were two types of defective catheters: one had a blunt tip that could not be inserted into the urethra, and the other had excessive lubricant inside the catheter tube, blocking it and preventing urine from flowing.If the catheter was defective, a second catheter needs to be used.Therefore, using a catheter consecutively twice increased the risk of developing a 'urinary tract infection.The customer was required antibiotics.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20745870
• Report Number: 1018233-2024-07375
• Device Sequence Number: 8756019
• Product Code: FCM
• UDI-Device Identifier: 00801741030567
• UDI-Public: (01)00801741030567(11)240524(17)260228(10)NGJR2350
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 4A5108
• Device Lot Number: NGJR2350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: Asian